Healthy InfantsBABIES INCT06789484
Characterization of the Gastrointestinal Microbiota in Newborn Infants
A study testing Probiotic in people with Healthy Infants, run by Hvidovre University Hospital at 1 site in Denmark.
Trial summary
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain. Read more about this study
- Who is it for?
- Ages Up to 1 dayHealthy volunteers can take part
- Conditions the study is for
- Healthy Infants
- What is being tested?
- Probiotic
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 4 Mar 2025to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 1 day
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy pregnant person in gestational week 36+0-38+0
- Age ≥ 18 years
- Normal singleton pregnancy
- Ability to read and speak Danish
- Normal ultrasound scan of the fetus at gestational age 19-20 weeks
- Plan to exclusively breastfeed
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- Provided voluntary written informed consent.
- Inclusions Criteria for the newborn:
- Born at full-term ≥37+0
- Birth weight above 2500 g
- APGAR score of at least 7 within the first 5 min of life.
Who cannot join
- Pregnancy at over 38+0 weeks' gestation at recruitment
- Multiple pregnancy
- Pregnancy with any fetal abnormality
- Alcohol or drug abuse
- Plan to give birth at other hospitals than Copenhagen University Hospital Hvidovre
- Any contraindications for breastfeeding.
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- Congenital disorders that could affect their safety or the study outcome
- Admission to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study which can interfere with this probiotic intervention
- No other probiotics than the study product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling
Hvidovre, 2650
Andreas Munk Petersen, MD, PhD, DMSc, +45 38 62 61 99, andreas.munk.petersen@regionh.dk
About this study
Official title: Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.
The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
- Conditions
- Healthy Infants
- Being tested
- Probiotic, Placebo
- Keywords
- Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProbioticOther
Given daily from enrollement to 28 days of life
PlaceboDietary supplement
Given daily from enrollement to 28 days of life
| Study group | Role | What they receive |
|---|---|---|
| Probiotic | Active comparator | Probiotic Dietary supplement Receives: Other: Probiotic |
| Placebo | Placebo comparator | Identical looking placebo consisting of maltodextrin Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recovery of the probiotic strain in newborn/infant fecal samples
Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.
Measured: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Secondary outcomes (3)
Infant fecal pH
Changes in Fecal pH measured in fecal water from fecal samples.
Measured: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Total abundance of bifidobacteria
Abundance of fecal bifidobacteria measured by quantitative PCR
Measured: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Infant fecal short chain fatty acids (SCFA)
Changes in SCFA production as measured by targeted metabolomics
Measured: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2025
- Study start4 Mar 2025
- Primary completion30 Oct 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy InfantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, controlled trial of healthy term in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hvidovre University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Chr Hansen
- Responsible party
- Principal investigator, Andreas Munk Petersen, Hvidovre University Hospital
- Investigators
- Andreas Munk Petersen, MD, PhD, DMSc, Principal investigator, Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06789484
- Sponsor's protocol ID
- HND-IN-056
- Other IDs
- H-24073138
- Acronym
- BABIES I
- Status last verified
- Apr 2025
- First submitted
- 6 Jan 2025
- Last updated
- 13 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recovery of a Probiotic in Term Newborns - a Randomized, Double-blinded, Placebo-controlled Proof-of-concept Study
- ClinicalTrials.gov ID
- NCT06789484
- Acronym / sponsor ID
- BABIES I / HND-IN-056
- Conditions
- Healthy Infants
- Keywords
- Infant, Gastrointestinal Microbiome, Diet, Food, and Nutrition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Hvidovre University HospitalUniversity, hospital or other
- Collaborators
- Chr Hansen
- Study start
- 4 Mar 2025 (actual)
- Primary completion
- 30 Oct 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 23 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The BABIES study is a single-center, randomized, double-blinded, placebo-controlled study in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period (Figure 1). The study will evaluate the seeding ability of supplementation with a probiotic strain.
The aim is to investigate the recovery and engraftment of the probiotic strain in infant fecal samples after 4 weeks supplementation using a strain specific quantitative Polymerase Chain Reaction (qPCR).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, controlled trial of healthy term in newborns with a 4-week intervention period from birth to 28 days of life followed by a 2-week follow-up period
| Arm | Type | Receives |
|---|---|---|
| Probiotic | Active comparator | Other: ProbioticProbiotic Dietary supplement |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboIdentical looking placebo consisting of maltodextrin |
Who may qualify
- Ages
- Up to 1 day
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- Inclusions Criteria for the newborn:
Key exclusion criteria (10 listed)
- Congenital disorders that could affect their safety or the study outcome
- Admission to Neonatal Intensive Care Unit for more than 24 hours
- Participation in another clinical intervention study which can interfere with this probiotic intervention
- No other probiotics than the study product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ProbioticGiven daily from enrollement to 28 days of life | Other | Probiotic |
| PlaceboGiven daily from enrollement to 28 days of life | Dietary supplement | Placebo |
Primary outcome
Recovery of the probiotic strain in newborn/infant fecal samples
Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Abundance of the probiotic strain in newborn/infant fecal samples measured by quantitative PCR.
3 secondary outcomes
Infant fecal pH
Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Total abundance of bifidobacteria
Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Infant fecal short chain fatty acids (SCFA)
Time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andreas Munk Petersen, MD, PhD, DMSc principal investigator
Center for Klinisk Mikrobiom Forskning, Gastroenheden og Klinisk Mikrobiologisk Afdeling, Hvidovre Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Probiotic in people with Healthy Infants, run by Hvidovre University Hospital at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sofie Ingdam Halkjær, MSc, PhD (+4541318174, sofie.ingdam.halkjaer@regionh.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recovery of the probiotic strain in newborn/infant fecal samples (time frame: Birth (first stool after meconium), 2 weeks, 4 weeks, and 6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2025.